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Am J Gastroenterol. 2009 Mar;104(3):546-51. doi: 10.1038/ajg.2008.22.

Robustness assessments are needed to reduce bias in meta-analyses that include zero-event randomized trials.

Author information

1
Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Denmark. erickeus@hotmail.com

Abstract

OBJECTIVES:

Meta-analysis of randomized trials with binary data can use a variety of statistical methods. Zero-event trials may create analytic problems. We explored how different methods may impact inferences from meta-analyses containing zero-event trials.

METHODS:

Five levels of statistical methods are identified for meta-analysis with zero-event trials, leading to numerous data analyses. We used the binary outcomes from our Cochrane review of randomized trials of laparoscopic vs. small-incision cholecystectomy for patients with symptomatic cholecystolithiasis to illustrate the influence of statistical method on inference.

RESULTS:

In seven meta-analyses of seven outcomes from 15 trials, there were zero-event trials in 0 to 71.4% of the trials. We found inconsistency in significance in one of seven outcomes (14%; 95% confidence limit 0.4%-57.9%). There was also considerable variability in the confidence limits, the intervention-effect estimates, and heterogeneity for all outcomes.

CONCLUSIONS:

The statistical method may influence the inference drawn from a meta-analysis that includes zero-event trials. Robustness assessments are needed to reduce bias in meta-analyses that include zero-event trials.

PMID:
19262513
DOI:
10.1038/ajg.2008.22
[Indexed for MEDLINE]

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